Signia” Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia” Power Handle, when used with Endo…
Medical device recall Z-1237-2018. Published in FDA’s Enforcement Report on Apr 4, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 4, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2121 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Product reportedly shutting down during use.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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2121, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
SIGPHANDLE-UDI #10884521543782 Serial# C17AAA0001 C17AAA0002 C17AAA0003 C17AAA0004 C17AAA0005 C17AAA0006 C17AAA0007 C17AAA0008 C17AAA0009 C17AAA0010 C17AAA0011 C17AAA0012 C17AAA0013 C17AAA0014 C17AAA0015 C17AAA0017 C17AAA0018 C17AAA0019…
Every code shown here, 1,997 characters
SIGPHANDLE-UDI #10884521543782 Serial# C17AAA0001 C17AAA0002 C17AAA0003 C17AAA0004 C17AAA0005 C17AAA0006 C17AAA0007 C17AAA0008 C17AAA0009 C17AAA0010 C17AAA0011 C17AAA0012 C17AAA0013 C17AAA0014 C17AAA0015 C17AAA0017 C17AAA0018 C17AAA0019 C17AAA0020 C17AAA0021 C17AAA0022 C17AAA0023 C17AAA0024 C17AAA0026 C17AAA0027 C17AAA0028 C17AAA0029 C17AAA0030 C17AAA0031 C17AAA0032 C17AAA0033 C17AAA0034 C17AAA0035 C17AAA0036 C17AAA0037 C17AAA0038 C17AAA0039 C17AAA0040 C17AAA0042 C17AAA0043 C17AAA0044 C17AAA0045 C17AAA0046 C17AAA0047 C17AAA0048 C17AAA0049 C17AAA0050 C17AAA0051 C17AAA0052 C17AAA0053 C17AAA0054 C17AAA0055 C17AAA0056 C17AAA0057 C17AAA0058 C17AAA0059 C17AAB0002 C17AAB0003 C17AAB0004 C17AAB0005 C17AAB0006 C17AAB0007 C17AAB0008 C17AAB0009 C17AAB0010 C17AAB0011 C17AAB0012 C17AAB0013 C17AAB0014 C17AAB0015 C17AAB0016 C17AAB0017 C17AAB0018 C17AAB0019 C17AAB0020 C17AAB0021 C17AAB0022 C17AAB0023 C17AAB0024 C17AAB0025 C17AAB0026 C17AAB0027 C17AAB0028 C17AAB0029 C17AAB0030 C17AAB0031 C17AAB0032 C17AAB0033 C17AAB0034 C17AAB0035 C17AAB0036 C17AAB0037 C17AAB0038 C17AAB0039 C17AAB0040 C17AAB0041 C17AAB0042 C17AAB0043 C17AAB0044 C17AAB0045 C17AAB0046 C17AAB0047 C17AAB0048 C17AAB0049 C17AAB0050 C17AAB0051 C17AAB0052 C17AAB0053 C17AAB0054 C17AAB0055 C17AAB0056 C17AAB0057 C17AAB0058 C17AAB0059 C17AAB0060 C17AAB0061 C17AAB0062 C17AAB0063 C17AAB0064 C17AAB0065 C17AAB0066 C17AAB0069 C17AAB0070 C17AAB0072 C17AAB0073 C17AAB0074 C17AAB0075 C17AAB0076 C17AAB0077 C17AAB0078 C17AAB0079 C17AAB0080 C17AAB0081 C17AAB0082 C17AAB0083 C17AAB0084 C17AAB0085 C17AAB0086 C17AAB0087 C17AAB0088 C17AAB0089 C17AAB0090 C17AAB0091 C17AAB0092 C17AAB0093 C17AAB0094 C17AAB0095 C17AAB0096 C17AAB0097 C17AAB0098 C17AAB0099 C17AAB0101 C17AAB0102 C17AAB0103 C17AAB0104 C17AAB0105 C17AAB0107 C17AAB0108 C17AAB0109 C17AAB0110 C17AAB0111 C17AAB0112 C17AAB0113 C17AAB0114 C17AAB0115 C17AAB0116 C17AAB0118 C17AAB0120 C17AAB0121 C17AAB0122 C17AAB0123 C17AAB0124 C17AAB0125 C17AAB0126 C17AAB0127 C17AAB0128 C17AAB0129 C17AAB0130…
FDA’s list runs to 23,600 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution: US (Nationwide).
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Dec 13, 2017.
- FDA classified it on Mar 27, 2018.
- FDA’s Enforcement Report published it on Apr 4, 2018.
- FDA terminated it on Apr 14, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Covidien LLC, of North Haven, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 23,600 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.